Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The evaluation of the endpoint sensitisation of 1,5-pentanediol (CAS 111-29-5) is based on a weight of evidence approach using the toxicological data of the chemical analogue 1,6-hexanediol (CAS 629-11-8) and main metabolite of 1,5-pentanediol d-valerolactone (CAS 542-28-9) (for WoE information, see chapter 13.2).


 


1,6-Hexanediol


GPMT


In the Guinea pig Maximization test performed under GLP according to guideline EU method B.6, ten female Pirbright-Hartley guinea pigs received six intradermal injections of 5% in 0.9% aqueous NaCl-solution resp. in Freunds adjuvant/0.9 % aqueous NaCl-solution (1:1), resp. 0.9 % aqueous NaCl-solution in groups of two per animal. An epicutanous application of 1,6-hexanediol followed one week later. For the challenge three weeks later, a concentration of 25% was applied via soaked filter stripes to the clipped flank of the animals under occlusive conditions for 24 hours. The readings 24 and 48 hours after patch removal did not reveal any signs of sensitizing effects.


 


d-Valerolactone


OECD 429, LLNA


Furthermore, the metabolite d-valerolactone (CAS 542-28-9) was not a skin senitizer in the Local Lymph Node Assay (Harlan CCR, 2012).


 


 


Conclusion:


Due to the structural similarities between 1,5‑pentanediol and 1,6‑hexanediol and the metabolization of 1,5-pentanediol to d-valerolactone in vivo the same results regarding the skin sensitisation can be expected and will be verified with the ongoing studies (BASF OECD 442 C,D,E (64V0359/20B080, 66V0359/20X117, 65V0359/20X116)). The results will be submitted as soon as the data are available.


 


 


 

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Justification for classification or non-classification

Due to the results of guideline studies conducted with the structural analogue 1,6-hexanediol and the metabolite d-valerolactone, no classification is necessary.